The US regulator will assess data from Phase I and Phase III clinical studies that compared the drug with Janssen’s reference product Remicade (infliximab).
The Incheon, Korea headquartered firm – a joint venture between conglomerate Samsung and Switzerland’s Biogen – said that, if approved, SB2 will be sold in the US by Merck & Co, known as MSD outside the US and Canada.
US drug giant Pfizer is expected to launch its own version of Remicade in the US last year.
The Pfizer drug was approved by the FDA in February and was the first biosimilar monoclonal antibody (mAb) to be cleared in the US.